EP1437972A1 - Endoskopisches system zur applikation einer vielzahl von blutgefässklammern - Google Patents

Endoskopisches system zur applikation einer vielzahl von blutgefässklammern

Info

Publication number
EP1437972A1
EP1437972A1 EP02778640A EP02778640A EP1437972A1 EP 1437972 A1 EP1437972 A1 EP 1437972A1 EP 02778640 A EP02778640 A EP 02778640A EP 02778640 A EP02778640 A EP 02778640A EP 1437972 A1 EP1437972 A1 EP 1437972A1
Authority
EP
European Patent Office
Prior art keywords
clip
inner shaft
shaft
jaws
cavity
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP02778640A
Other languages
English (en)
French (fr)
Other versions
EP1437972B1 (de
Inventor
John J. Damarati
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
Original Assignee
Boston Scientific Ltd Barbados
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Ltd Barbados filed Critical Boston Scientific Ltd Barbados
Publication of EP1437972A1 publication Critical patent/EP1437972A1/de
Application granted granted Critical
Publication of EP1437972B1 publication Critical patent/EP1437972B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227Spring clips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00296Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means mounted on an endoscope
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2901Details of shaft
    • A61B2017/2905Details of shaft flexible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B17/2909Handles
    • A61B2017/2912Handles transmission of forces to actuating rod or piston
    • A61B2017/2924Translation movement of handle without rotating movement
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/53Means to assemble or disassemble
    • Y10T29/53709Overedge assembling means
    • Y10T29/53783Clip applier

Definitions

  • the present invention relates to a system for clipping body tissue, such as a system for introducing a clip for hemostasis ("hemoclip") endoscopically in the GI tract.
  • hemoclip a clip for hemostasis
  • Patent No. 3,958,576 assigned to Olympus Optical Co. Ltd. of Japan. See also Japanese Patent Publication No. 04102450 and U.S. Patent No. 5,766,189. Each of these devices is used to insert a single clip, and includes a series of mechanical members to insert, eject and close or clamp the clip at a desired location, such as for hemostasis in the GI tract.
  • the present invention provides an improved hemoclip system.
  • multiple clips can be applied internally by way of a conventional endoscope without removal and reinsertion of a clip-retaining member.
  • the system provides good control of the rotated position of a clip, with little backlash, for convenient and reliable placement of a clip or clips.
  • FIGURE 1 is an enlarged side elevation of the distal portion of a multiple hemoclip system for an endoscope in accordance with the present invention with parts shown in section;
  • FIGURE 6 is a top perspective of a second embodiment of a hemoclip usable in the system of the present invention
  • FIGURE 7 is a top perspective of a third embodiment of a hemoclip usable in the system of the present invention.
  • FIGURE 8 is a side elevation of a fourth embodiment of a hemoclip usable in the system of the present invention.
  • FIGURE 9 is a vertical section along line 9-9 of FIGURE 5;
  • FIGURE 10 is a vertical section corresponding to FIGURE 9 showing aspects of an alternative embodiment of a hemoclip usable in the system of the present invention;
  • FIGURE 11 is a vertical section corresponding to FIGURE 9 showing aspects of a further embodiment of a hemoclip usable in the system of the present invention.
  • FIGURE 12 is a diagrammatic top perspective of the proximate portion of a multiple hemoclip system for an endoscope in accordance with the present invention.
  • FIGURE 13 is a side elevation of the proximate portion shown in FIGURE 12, with parts broken away;
  • FIGURE 14 is a top plan of a second embodiment of a proximate portion of a multiple hemoclip system in accordance with the present invention, with parts broken away;
  • FIGURE 15 is a top plan of a third embodiment of a proximate portion for a system in accordance with the present invention, with parts broken away;
  • FIGURE 16 is a top plan of a fourth embodiment of proximate portion for a system in accordance with the present invention, with parts broken away; and
  • FIGURE 17 is a top plan of a fifth embodiment of a proximate portion for a system in accordance with the present invention, with parts broken away.
  • a hemoclip system 10 in accordance with the present invention includes an elongated outer tube or shaft 12 which may be inserted through a conventional scope for positioning a distal, clip-carrying portion 14 of the shaft at a desired location of the body, such as a location of bleeding to be clamped.
  • elongated outer tube or shaft 12 can be manufactured from an extruded biocompatible polymer or other suitable material.
  • the proximate end portion of the outer shaft connects to a handle as described below with reference to FIGURES 12-17 for external control of the relatively movable component parts of the distal portion 14.
  • An inner shaft 16 is slideably received within the outer shaft 12, and also may be manufactured from an extruded biocompatible polymer or other suitable material. The longitudinal position of the inner shaft 16 relative to the outer shaft 12 can be adjusted.
  • the clips 20 can be manufactured from a metal with spring and/or memory properties, such as stainless steel or Nitinol.
  • the basic shape is a thin band plate, bent toward its center or web 28 to form a long U with elongated opposing jaws 30.
  • the ends of the jaws are bent inward to form teeth 32 that face each other.
  • the inner ends of the teeth can be sharpened to form grabbing hooks.
  • a clip opener component 34 is secured at the distal end of the inner shaft 16, such as by attachment to the strengthening wires 22 (shown in the cross-section of FIGURE 3). Such wires preferably extend the full length of the inner shaft.
  • the clip opener includes a continuous shell 36 at its proximate end and two side pieces 38 at its distal end. As seen in FIGURE 4, the proximate portion or shell 36 tapers inward at opposite sides 37 (this tapering and other dimensions are exaggerated in the drawings for ease of illustration and description). The distal or leading ends of the clip jaws are similarly tapered.
  • a clip 20 is "loaded” by forcing it forward, using the pusher block 24.
  • Each side piece has proximate wedge surfaces 40 (FIGURE 1) angled outward from the center line of the device and configured such that the distal ends of the clip jaws are wedged apart when the pusher block moves the clip against the opener surfaces 40. Consequently, as a clip is forced forward along the cavity 18 of the inner shaft 16, the clip teeth 32 and jaws 30 are wedged apart to the condition illustrated at the right of FIGURE 1, contrary to the natural memory or spring characteristics of the clip. This action tends to spread the side pieces 38 apart until the central portion or web 28 of the clip fits within an intermediate cavity portion 42 of the clip opener 34. When this position is reached, the clip is reliably held in the clip opener with its jaws open.
  • the opened clip can be moved by manipulation of the outer shaft or tube 12, and can be rotated by manipulation of the inner tube or shaft 16.
  • the clip can be ejected by withdrawing the inner shaft 16 relative to the outer shaft 12.
  • projections 44 on the outer sides of the clip jaws 30 are positioned to engage against a metal collar 46 provided at the end of the outer shaft 12.
  • the opener side pieces 38 are wedged apart, in the direction of the arrows 48.
  • the clip edges can have weakening nicks 50 (shown only in FIGURE 2) that allow the metal of the jaws to bend inward as the jaws move past the opener side pieces 38, until the clip is released and its teeth 32 move toward each other to clamp the tissue at the desired site, due to the inherent spring or memory characteristics of the clip. After dispensing of one clip, the next clip can be moved into position by manipulation of the core wire 26 and attached pusher 24.
  • the outer periphery of the inner shaft 16 can have equally spaced ribs 52 for ease in sliding along the inner periphery of the outer shaft 12.
  • the shafts and core wire 26 can be curved or bent during use, depending on the application.
  • closing force for the clip 20 can be achieved or augmented by a separate elastic band 52.
  • One or more of the clip components can be bioabsorbable, so that the clip would automatically be released over time.
  • the clip jaws 30 can be of rectangular cross-section (FIGURE 9) or can be arcuate (FIGURE 10) or angled (FIGURE 11) for increased rigidity.
  • the proximate portion 54 of the multiple hemoclip system in accordance with the present invention can be in the form of a handle having separate components for positioning the outer shaft 12 and manipulating the inner shaft 16 and core wire 26 connected to the clip opener and pusher, respectively.
  • the parts are shown diagrammatically.
  • the outer shaft 12 is coupled to a larger fitting 56 leading to a bracket portion 58 that can more easily be grasped and positioned by a user.
  • the inner shaft 16 is coupled to a proximate extension 60 leading to a finger hole 62. Most of the extension 60 is cylindrical, but an operating knob 64 is journaled on a short noncylindrical portion 66 of the extension.
  • the knob can be turned to rotate the inner shaft, but is slideable along the noncylindrical portion 66. Sliding movement of the extension relative to the knob 64 is limited by stops 68 at both sides. Since the knob is held within the bracket 58, stops 68 define the maximum travel of the inner shaft 16 inside the outer shaft 12.
  • the core wire 26 is coupled to a sliding spool 70.
  • the spool is moveable fore and aft (distally and proximally) along the extension 60, for moving the core wire and attached clip pusher relative to the inner shaft 16.
  • the proximate portion 54 can be manipulated to position a clip adjacent to a site to be clamped, whereupon the spool 70 is moved distally to slide the core wire 26 and clip pusher 24 sufficiently to position the distal most clip as shown at the right of FIGURE 1.
  • Knob 64 can be used to rotate the inner shaft to orient the clip as desired. Only a short relative movement of the inner and outer shafts is required to eject the clip, which will relax toward its closed position to apply a clamping force at the desired site. Thereafter, the device need not be removed and reloaded. Rather, the next clip can be moved forward and the process repeated to secure another clip. Removal of the distal portion of the multiple hemoclip system is not required until the supply of preloaded clips has been exhausted.
  • FIGURE 15 is identical to the embodiment of FIGURE 14 except for the mechanism for moving the core wire 26.
  • the spool portion 70 carries a rotatable dial 76 having indicia 78.
  • the core wire 26 connects to or is wrapped around an internal segment of the dial such that rotation of the dial moves the core wire 26 (and attached clip pusher) inside the inner shaft 16.
  • the indicia 78 can be used to determine the position of the clips at the distal end and/or the number of clips remaining to be dispensed.
  • the fitting 56 connected to the outer shaft 12 is identical to that used in the embodiment of FIGURES 12 and 13, including the bracket portions 58.
  • the inner shaft 16 connects to the extension 60, with a non-circular segment 66 on which the knob 64 is journaled, and stops 68 limiting the relative movement of the inner and outer shafts.
  • the spool section 70 is fixed to the extension 60. Core wire 26 is moved relative to the spool (and, consequently, relative to the inner shaft) by a slide operating mechanism of the type described above with reference to FIGURE 14.
  • the external button 72 is slideable lengthwise of component 70 for moving the core wire 26, and indicia 74 can be used to determine the position of the clips and the number of clips remaining.
  • FIGURE 17 is identical to the embodiment of FIGURE 16 except for the mechanism for moving the core wire 26.
  • a dial mechanism of the type described above with reference to FIGURE 15 is used.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
EP02778640A 2001-10-24 2002-10-24 Endoskopisches system zur applikation einer vielzahl von blutgefässklammern Expired - Lifetime EP1437972B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US34783201P 2001-10-24 2001-10-24
US347832P 2001-10-24
PCT/US2002/034304 WO2003034928A1 (en) 2001-10-24 2002-10-24 Multiple hemoclip system for an endoscope

Publications (2)

Publication Number Publication Date
EP1437972A1 true EP1437972A1 (de) 2004-07-21
EP1437972B1 EP1437972B1 (de) 2006-11-22

Family

ID=23365472

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02778640A Expired - Lifetime EP1437972B1 (de) 2001-10-24 2002-10-24 Endoskopisches system zur applikation einer vielzahl von blutgefässklammern

Country Status (7)

Country Link
US (6) US6679894B2 (de)
EP (1) EP1437972B1 (de)
JP (1) JP4237626B2 (de)
AU (1) AU2002340291B2 (de)
CA (1) CA2433040A1 (de)
DE (1) DE60216309T2 (de)
WO (1) WO2003034928A1 (de)

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AU2002340291A2 (en) 2003-05-06
AU2002340291A1 (en) 2003-05-06
US6679894B2 (en) 2004-01-20
DE60216309T2 (de) 2007-06-28
US20080065118A1 (en) 2008-03-13
US20150112367A1 (en) 2015-04-23
WO2003034928A1 (en) 2003-05-01
AU2002340291B2 (en) 2009-01-08
DE60216309D1 (de) 2007-01-04
US8133240B2 (en) 2012-03-13
CA2433040A1 (en) 2003-05-01
JP4237626B2 (ja) 2009-03-11
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US8936610B2 (en) 2015-01-20
US20120136376A1 (en) 2012-05-31
US20060259045A1 (en) 2006-11-16
US9730702B2 (en) 2017-08-15
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JP2005506870A (ja) 2005-03-10
US20030083677A1 (en) 2003-05-01

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